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Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial)
- Source :
- The BMJ, BMJ
- Publication Year :
- 2020
- Publisher :
- BMJ, 2020.
-
Abstract
- ObjectiveTo investigate the effectiveness of using convalescent plasma to treat moderate coronavirus disease 2019 (covid-19) in adults in India.DesignOpen label, parallel arm, phase II, multicentre, randomised controlled trial.Setting39 public and private hospitals across India.Participants464 adults (≥18 years) admitted to hospital (screened 22 April to 14 July 2020) with confirmed moderate covid-19 (partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio between 200 mm Hg and 300 mm Hg or a respiratory rate of more than 24/min with oxygen saturation 93% or less on room air): 235 were assigned to convalescent plasma with best standard of care (intervention arm) and 229 to best standard of care only (control arm).InterventionsParticipants in the intervention arm received two doses of 200 mL convalescent plasma, transfused 24 hours apart. The presence and levels of neutralising antibodies were not measured a priori; stored samples were assayed at the end of the study.Main outcome measureComposite of progression to severe disease (PaO2/FiO2ResultsProgression to severe disease or all cause mortality at 28 days after enrolment occurred in 44 (19%) participants in the intervention arm and 41 (18%) in the control arm (risk difference 0.008 (95% confidence interval −0.062 to 0.078); risk ratio 1.04, 95% confidence interval 0.71 to 1.54).ConclusionConvalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality. This trial has high generalisability and approximates convalescent plasma use in real life settings with limited laboratory capacity. A priori measurement of neutralising antibody titres in donors and participants might further clarify the role of convalescent plasma in the management of covid-19.Trial registrationClinical Trial Registry of India CTRI/2020/04/024775.
- Subjects :
- Adult
Male
medicine.medical_specialty
Pneumonia, Viral
India
030204 cardiovascular system & hematology
Antibodies, Viral
Corrections
law.invention
Betacoronavirus
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Fraction of inspired oxygen
Internal medicine
medicine
Humans
Treatment Failure
Pandemics
COVID-19 Serotherapy
030304 developmental biology
Oxygen saturation (medicine)
0303 health sciences
SARS-CoV-2
business.industry
Research
Immunization, Passive
Absolute risk reduction
COVID-19
General Medicine
Middle Aged
Antibodies, Neutralizing
Confidence interval
Clinical trial
Relative risk
Disease Progression
Arterial blood
Female
Coronavirus Infections
business
Subjects
Details
- ISSN :
- 17561833
- Database :
- OpenAIRE
- Journal :
- BMJ
- Accession number :
- edsair.doi.dedup.....cc7c74335a287b4099d7bd58c9b7f7f2